University of Texas Medical Branch at Galveston failed to euthanize monkeys dying from Ebola-MarburgMedia Coverage About SAEN Stop Animal Exploitation Now

Please levy the MAXIMUM FINE against the University of Texas, Medical
Branch, Galveston for their blatant disregard of the Animal Welfare Act when
their ineptitude allowed many monkeys to die painfully without being
euthanized. Their utter disregard for the animals and the Animal Welfare Act
CANNOT be tolerated and MUST be punished to the fullest extent of the law.

University of Texas Medical Branch at Galveston failed to
euthanize monkeys dying from Ebola-Marburg
By Merritt Clifton,
Animals 24-7, September 1, 2015

GALVESTON, Texas––A recent investigation of a disease in the Ebola
family done at the University of Texas Medical Branch at Galveston involved
alleged “critical, major, and minor” violations of animal welfare
protocols, according to an audit by the National Institute of Allergy &
Infectious Diseases.

The NIAIA audit report, summarizing findings by an investigative team on
January 26-29, 2015, was edited “by agreement” of the University of Texas
Medical Branch at Galveston and NIAIA personnel in more than 145 places to
remove the names of almost everyone involved in the alleged violations
before it was released to Stop Animal Exploitation Now cofounder Michael A.
Budkie.

Tipped off to the existence of the NIAIA audit report by a University of
Texas Medical Branch insider, Budkie obtained a copy of it through the
Freedom of Information Act.

Among the names left legible in the report, occurring in at least three
places, was that of Thomas Geisbert, long the biggest name in Ebola
research, who was identified as project leader for the study Infectivity
and Lethality of Marburg Virus Angola in Non-Human Primates Following
Intramuscular Challenge.

But the intensive redaction to remove names left Geisbert’s role in
connection with the alleged “critical, major, and minor” violations
unclear.

Geisbert himself did not respond to anANIMALS 24-7 request for comment.

“The project which was the subject of the audit was not one in which
Geisbert was the principal investigator,” opined Budkie. “So, he isn’t
particularly relevant to the audit,” a perspective apparently contradicted
by Geisbert’s position as project leader.

Par for the course?

“However, the primary animal issue of the audit––allowing monkeys to die
without receiving euthanasia, is par for the course at the Galveston
National Lab, according to our source,” Budkie said.

“Also, to me,” Budkie continued, “the most striking issue of the NIAID
audit isn’t really the animal issue as much as the sheer number and severity
of the deficiencies listed there. Also, from what I am told, the University
of Texas Medical Branch administration was engaging in something of a
cover-up regarding the report. Both the Institutional Animal Care & Use
Committee and the attending veterinarian were denied access to the report,
which would be illegal in and of itself,” Budkie charged.

“So, once I had the report, I e-mailed it to the entire animal care
staff, etc. Thought they should see it,” Budkie said.

“A matter of utmost importance” wrote Budkie to University of Texas
system chancellor Bill McRaven on August 14, 2015, “I am contacting you
about a matter of the utmost importance, research integrity within the
University of Texas system. I was contacted by a whistleblower who has/had
a connection to the University of Texas, Medical Branch/Galveston National
Laboratory.

This person provided me with information concerning the existence of a
National Institutes of Allergies and Infectious Diseases site visit report
that was highly critical of several research projects at UTMB/GNL. I have
since obtained a copy of the report, which is attached to this
communication, via the Freedom of Information Act.

The report, Budkie explained to McRaven, “reveals conditions that
clearly had a serious and deleterious impact on the health and well-being of
animals within UTMB/GNL laboratories. I have already provided this report to
the USDA Animal & Plant Health Inspection Service,” Budkie said, which
according to Budkie had already done “an inspection to specifically address
issues relevant to SAEN’s complaint.”

Monkey deaths called “Loss of Data”

Data the cyborg, from StarTrek.com, was not among the non-human primates
who were “lost” to Ebola-Marburg.

Budkie called McRaven’s attention to a section of the NIAIA report headed
“Loss of Data.” Said the report of the non-human primates who had been
exposed to the Marburg variant of Ebola virus, “Most animals (8 of 12) were
found dead between Days 8 and 10. Since approximately 12-18 hours had
elapsed between the last observations, when the animals were still alive,
and when the animals were found dead the next morning, it is unknown how
long these animals might have suffered before dying. This is an animal
welfare issue despite the fact that the protocol states that ‘animals will
be observed at minimum twice daily . . . . observations will increase in
number as clinical signs warrant.”

Continued the NIAIA report, “It is unacceptable to leave animals that
are expected to die unattended during the time frame that death is expected
(Days 7-10 for Marburg virus). Even more of a concern, is the fact that
collectively, data were available for all of these animals showing evidence
of Marburg virus disease during the expected time of death.”
90 Critical, Major, & Minor deficiencies

Altogether, Budkie summarized to McRaven, “This report lists
approximately 90 Critical, Major and Minor deficiencies discovered by NIAID
during their site visit. The extremely high number of deficiencies must
raise serious questions as to the conduct of these specific research
projects, as well as the overall integrity of experimentation at the
University of Texas Medical Branch/Galveston National Laboratory.

“In brief,” Budkie wrote, “the report states that a significant number
(75%) of primates who were infected with Marburg virus were denied adequate
veterinary care, (i.e. were not adequately observed or euthanized in a
timely manner) and as a result were allowed to suffer an extremely painful
death unnecessarily since death was not an endpoint of the studies in
question. Additionally, this report reveals serious issues relevant to:
failure to follow Standard Operating Procedures (SOPs); inaccurate,
incomplete, & faulty documentation; seriously compromised experimental
data, etc.

“Eleven of these citations were ‘Critical,’” Budkie pointed out,
meaning that according to the NIAIA report itself, they “would affect the
validity or integrity of a study and/or the acceptability of a Contract
Research Organization (CRO). Regulatory Authority action is probable.”

Asked for investigation

Another 59 alleged violations were ‘Major,’ Budkie added, which
according to the NIAIA report mean a procedural deficiency that “may
jeopardize the acceptability” of the findings of an experiment, and that
“Regulatory Authority action is possible.”

Budkie asked McRaven to “immediately institute an independent
investigation of the experiments connected to this site visit, as well as
all use of primates at University of Texas Medical Branch/Galveston National
Laboratory relevant to compliance with the federal Animal Welfare Act,
University of Texas Standard Operating Procedures (SOPs), Good Laboratory
Practices (GLPs) and NIAID policies. As you can see from the attached
report,” Budkie warned, “UTMB/GNL’s status as a Contract Research
Organization for the NIAID is apparently in danger.”

Responding at McRaven’s request, University of Texas system vice
chancellor for health affairs Raymond S. Greenberg on August 24, 2015 wrote
to Budkie that he had received “all of the relevant documentation related to
the NAIAD report, as well as subsequent communication between UTMB and
NIAD, and information about an independent review conducted by USDA (orally
presented but not yet received in writing.) Dr. Patricia Hurn, vice
chancellor for research & innovation, has reviewed all of the written
documentation,” Greenberg said, “and has been in daily contact with Dr.
David Neisel, the vice president for research at UTMB.

“Dr. Hurn and I share the opinion that UTMB has responded in a timely,
thorough, honest, and concerned manner to the issues that were initially
raised by NIAID,” Greenberg said. “Virtually all of the issues raised by
NIAID have been addressed. With two federal agencies already engaged in
reviewing this matter, we believe that a third independent review by the
University of Texas system would be unlikely to add useful information not
already covered by the ongoing reviews.”

Budkie took case to feds

Budkie, however, had on August 19, 2015 sent another request for
investigation to Axel Wolff, director of compliance oversight for the
National Institutes of Health Office of Laboratory Animal Welfare National
Institutes of Health.

“A source connected to the University of Texas Medical Branch informed
Stop Animal Exploitation Now of an NIAID site visit report that raises many
serious issues relevant to animal welfare,” Budkie opened. “Chief among
these is that primates with Marburg virus are not being euthanized when they
reach a humane endpoint, and are simply dying overnight.

“However, the handling of this NIAID report within UTMB is a major
concern,” Budkie emphasized. “Our source has told us that this report was
withheld from both the attending veterinarian and the Institutional Animal
Care & Use Committee, preventing them from performing an investigation as
is required whenever a credible source (such as the NIAID site visit team)
raises a question regarding animal welfare issues.

“Also,” Budkie wrote, “we have been told that the bio-containment
veterinarian has not been informing the IACUC of primate deaths within the
Galveston National Laboratory, so they have not been able to address
potential animal care issues.

“Additionally,” Budkie finished, “the attending veterinarian for this
facility was recently terminated. On the day before termination, this
veterinarian filed a 13-point complaint about animal care issues with the
IACUC. It is unclear if this complaint was ever investigated.”

Responded Wolff overnight, “The Division of Compliance Oversight will
open an investigation into these allegations and provide you with an
assessment upon completion.”

Study funded coincidental with West African outbreak

According to the NIAID Quality Audit Report, “The conduct and reporting
for audit of Study Number STDY-13-0005-TG, entitledInfectivity and Lethality
of Marburg Virus Angola in Non-Human Primates Following Intramuscular
Challenge was scheduled for evaluation for data completeness and integrity
by Dr. Lynda Lanning, Dr. E1izabeth Glaze, Dr. William Dowling and Ms.
Kathleen Andrews.”

The study was apparently funded in March 2014, coinciding with the
outbreak of an Ebola virus pandemic now raging in six African nations for 17
months, killing more than 12,000 people. Another 28,000 have fallen ill.
Altogether, more than five times as many people have died from the present
Ebola outbreak as from all previous Ebola outbreaks combined since the
disease was first discovered in 1976.

But the outbreak had barely begun when the National Institutes of Health
allocated more than $26 million to a team led by Geisbert “to advance
treatments of the highly lethal hemorrhagic fever viruses known as Ebola and
Marburg,” summarized Rick Cousins for the Houston Business Journal.

Bioterrorism concern

The funding was awarded, Cousins continued, because “Ebola and Marburg
are considered to have the most potential to be used in a deadly
bioterrorism attack. There are currently no treatments, vaccines or
antidotes for these dangerous pathogens.”

Geisbert and the University of Texas Medical Branch, Cousins wrote, “will
use the grant over a five-year period in collaboration with the Maryland
company Profectus Biosciences Inc., the British Columbia company Tekmira
Pharmaceuticals, and the Vanderbilt University Medical Center in Nashville,
Tennessee.

Said Geisbert then, “This research impacts public health in areas where
the viruses are endemic, but also presents opportunities in the
biotechnology sector to develop treatments for people that visit these
areas, such as tourists, or soldiers. The approaches we are using are
applicable to combating other infectious diseases, especially deadly
emerging infectious diseases, for which countermeasures do not yet exist.”

Concluded Cousins, “The [University of Texas medical branch] will
conduct three interdependent research projects, supported by the Galveston
National Laboratory at UTMB, a facility with the highest level containment
required to safely work with deadly viruses, biosafety level four (BSL-4).
UTMB has the only operational BSL-4 laboratory on a university campus in
the United States.”

“Save the world!”

The West African Ebola pandemic elevated the status of the Geisberg-led
study from “only” that of a major biomedical research project to that of
research that might help save the world from one of the most lethal and
ugliest diseases known to pass from animals to humans.

The native hosts of Ebola viruses are believed to be fruit bats.
Explained an October 2014 World Organization for Animal Health (OIE) media
release, "When bats and other vertebrate species were experimentally
inoculated, only bats became infected and shed virus in feces without
showing any clinical signs. Monkeys are not considered as natural hosts
because of their high sensitivity to the virus and their high mortality rate
when infected,” but monkeys and great apes are frequently susceptible in
the wild.

“Ebola is a disease transmitted from wild animals to humans most likely
through hunting and collection of sick or dead wild animals and handling or
consumption of uncooked bush meat,” the OIE release continued. “Although
the source of infection for non-human primates often remains unclear, most
evidence indicates direct infection from one or more natural hosts,” namely
contact with fruit bats.

“Human to human transmission occurs through contact with body fluids of
an infected person. It is thought that the current epidemics throughout
West Africa originated from a single animal-human transmission event that
occurred in the forest at the border between Guinea, Sierra Leone and
Liberia,” the OIE said.

Geisbert, 53, had already been the biggest name in Ebola research for
more than 20 years.

“Ebola has fascinated Geisbert since he first looked at the tiny particle
through an electron microscope, noting its spaghetti-like shape with the
characteristic shepherd’s crook on the end,” recounted Washington Post
staff writer Nelson Hernandez on October 2, 2005, shortly after Geisbert
developed the first vaccine for Ebola.

“Not long after,” Hernandez continued, Geisbert “co-discovered a strain
that had broken out among research monkeys in Reston(Virginia), a tale that
made its way into Richard Preston’s 1994 bestseller The Hot Zone and made
Geisbert a celebrity in the science world.”

By the end of 2014 Geisbert was a rock star to the rest of the world,
too.

“Time Magazine‘s 2014 Person of the Year is not one but many –– the Ebola
Fighters,” editorialized Time on December 10, 2014. “Among those
spotlighted is Thomas Geisbert, professor of microbiology and immunology,
who is currently testing potential vaccines and treatments at the Galveston
National Laboratory.”

What the audit report says

The major mentions of Geisbert in the NIAIA audit report are in an
appendix that describe his participation in a meeting held on January 29,
2015 at which University of Texas Medical Branch at Galveston senior
personnel discussed the audit report findings with the NIAIA investigators.

“The date and time of the meeting were changed,” the appendix states,
“to accommodate Dr. Geisbert’s schedule.”

Three pages later, the appendix summarizes, “Dr. Geisbert asked for
clarification regarding the use of the human pathologist to read the slides”
of infected non-human primate tissues. “He asked if the issue was that an
amendment should have been issued or if it was an issue with the fact that a
veterinary pathologist was not used. Dr. [Lynda] Lanning [of NIAIA]
indicated that both were issues. The change should have been captured in a
Protocol Amendment and the pathologist evaluating the microscopic slides
should have been familiar with the species of animal from which the tissues
originated.”

A page later, “Dr. Geisbert asked if the audit team was looking at DVMAX
[data tracking software] printouts when finding issues in the data across
forms. Dr. Lanning stated that it was one of the types of documentation
that did not match across other originally collected data. Dr. Geisbert
said that could be the problem. Dr. Lanning reiterated that it is all raw
data and that the laboratory cannot pick and choose what raw data to include
in the study file and provide for review.”

“Geisbert was deeply involved in the research studies,” a well-informed
source in virology told ANIMALS 24-7. “Tom Geisbert is a very meticulous
guy and honorable guy,” the source continued. “I’d swear by him. I doubt
he was careless but it doesn’t take much to overlook a necessary detail.
Nobody’s perfect, although that is essential” when dealing with virus as
deadly as Ebola-Marburg.

Fair Use Notice: This document, and others on our web site, may contain copyrighted
material whose use has not been specifically authorized by the copyright owners. We believe that this not-for-profit, educational use on the Web constitutes a fair use
of the copyrighted material (as provided for in section 107 of the US Copyright Law). If you wish to use this copyrighted material for purposes of your own that go beyond fair use, you must obtain permission from the copyright owner.